Rotating operating anoscope

ABSTRACT

An anoscope includes a first hollow body open at opposite ends and a second hollow body open at opposite ends shapingly coupled with the first hollow body and arranged to coaxially rotate inside the first hollow body, the second hollow body being provided with a window arranged to make a portion of rectal mucous accessible. The window has an operating window and has dimensions and a shape such as to enable a surgical device to intervene on the portion. An angular positioning element is arranged to regulate the angular position of the second hollow body in the first hollow body in preset reciprocal angular positions, which reciprocal angular positions correspond to a same number of positions that can be taken up by the window.

This application is the US national phase of international applicationPCT/1B 2003/003781 filed 5 Sep. 2003, which designated the U.S. andclaims benefit of IT M02002A000246, dated 9 September 2002,the entirecontents of each of which are hereby incorporated by reference.

The present invention concerns an anoscope that can be used inproctology as a diagnostic and/or surgical instrument, said anoscopebeing provided with a guided-rotation device that is particularly usefulfor carrying out surgical treatment of haemorrhoids.

Anoscopes are prior-art instruments that are used in general medicine,gastroenterology, proctology, endoscopy and general surgery.

A generic anoscope usually comprises a portion called “speculum”, havinga cylindrical or tapered-cylindrical shape, that can be handled by anoperator by a grip and that is arranged to be inserted through the anusinto the terminal segment of the rectum of a patient. The speculum ishollow, open at opposite ends, and is inserted together with a dilatorthat has a cylindrical shape with a rounded end and which is providedwith a smooth surface, and is furthermore substantially longer than thespeculum. The dilator is accommodated inside the speculum during theinsertion manoeuvre and acts by distending the muscular wall of therectum without harming the mucous membrane thereof. Once the maneuverhas been completed the dilator is extracted whilst the speculum remainsin place.

In this way temporary dilatation that is restricted to the terminalsegment of the intestinal lumen is obtained, and such dilatation can beused to easily insert further instruments and thus carry out diagnosticand/or surgical operations.

One of the methods for surgically treating hemorrhoids involvesobliterating the arterial branches that are afferent to them, i.e.binding through suturing the walls of these vessels in such a way as toform a constriction that interrupts the blood flow towards thehaemorrhoids.

For this purpose anoscopes are used wherein the above-mentioned speculumhas a cut on its side wall in such a way as to create an ‘operatingwindow’ through which surgical instruments (forceps, suture needleholders) come into contact with the intestinal mucous membrane inproximity to the operating site, taking advantage of the fact that themucous membrane protrudes inside the speculum at the above-mentionedwindow.

One disadvantage of said anoscopes consists of the fact that theoperating window opens on a set area of the speculum. If, as generallyhappens, a surgeon has to treat several hemorrhoids in a same patientduring a single operation, the speculum must be rotated so as toreposition the window near the arterial branch concerned. To carry outthis maneuver, it is necessary to first insert the previously describeddilator to distend the rectal mucous membrane at the operating windowand thereby prevent the mucous membrane being ‘pinched’ in the windowduring shifting of the latter. The speculum is then gripped and it isrotated around its longitudinal axis according to a rotation angle thatis such as to place the window in the desired position.

Obviously, such manoeuvres lengthen the duration of the operation forthe surgeon and therefore subject the patient undergoing the surgery togreater distress.

U.S. Pat. No. 6,126,594 discloses an anoscope that can be used to treathemorrhoids and which is characterized by the presence of a plurality ofopenings arranged parallel to one another in the body of the speculum,in such a way as to provide a surgeon with a multiplicity of operatingwindows that can be used simultaneously. In practice, such device hasthe disadvantage that the rectal mucous membrane may simultaneouslyprotrude into a plurality of zones, thereby obstructing the internalcavity of the speculum, i.e. the field of operation itself. Anoscopeshave also been created (see for example the “Welch Allyn” model38850/38900), wherein the speculum is movable, being hinged on a fixedportion and therefore being rotatable around its own longitudinal axis.Such anoscopes are, however, made for merely diagnostic purposes, i.e.in order to enable a 360° view of the lumen of the rectum and areprovided with a window that extends over the entire length of the partof the body of the speculum that is inserted (i.e. that portion ofspeculum that is actually inserted into the rectal canal).

This technical expedient is certainly useful for exploring the terminalsegment of the intestinal cavity without neglecting any area of themucous membrane, but which causes a massive protrusion of the mucousmembrane itself within the speculum that is due to the dimensions of thewindow. As has already been said, a such phenomenon is disadvantageousduring a surgical operation because it causes undesired visual andmaterial obstruction of the operating area.

Furthermore, new surgical techniques are becoming widespread forperforming which the prior-art instruments are not always suitable. Forexample, Dr Francesco Sias (Santa Rita Clinic, Cagliari) recentlyperfected a method (haemorrhoidal dearterialization with transanalanopexy) that enables hemorrhoids to be treated surgically in a dayhospital, that can be carried out without anaesthesia. Such method isbased on an anatomical feature, i.e. on the constant presence(documented by Doppler echography) of 6 terminal arterial branchescoming from the lower haemorrhoidal artery, said arterial branches beingarranged along the wall of the rectum according to a precise geometryand at the end of which the hemorrhoids appear.

In fact, by arranging a patient in a prone position, so as to have theanal opening arranged frontally, the above-mentioned 6 arterial branchesare placed on an imaginary clock-face at 1 o'clock, at 3 o'clock, at 5o'clock, at 7 o'clock, at 9 o'clock, at 11 o'clock. The surgeon may thusmake a ligature of said arterial branches (through a so-called “Z”suture) by intervening above the haemorroids. Furthermore, the region ofmucous membrane of the rectum subjected to the operation issubstantially devoid of sensitive nerves, thus making local anaesthesiaunnecessary. Such an operation enables operating time to be halvedcompared with other types of surgical treatment of hemorrhoids and doesnot require the patient to be admitted as an inpatient.

However, this method requires a plurality of sutures to be carried outin preset positions.

It is obvious that none of the anoscopes disclosed up until now is idealfor the application of the method. In fact, by using an anoscope with asingle window the instrument has to be rotated six times during theoperation, with the disadvantages illustrated previously. It would besimilarly disadvantageous to use an anoscope with multiple windows or arotating anoscope, because in both cases the intestinal mucous membranewould take up an undesirable amount of space in the field of operation.

In addition, it should be added that none of the above-mentionedinstruments is provided with devices that help the surgeon to positionthe operating window exactly at the arterial branch that is to besutured.

An aim of the present invention is to improve the anoscopes that can beused in operating practice.

A further aim is to provide an anoscope equipped with operating windowsthat can be positioned near the arterial branches to be treated withouthaving to rotate the entire instrument.

Another aim is to provide operating windows of dimensions such as tomake accessible only the portions of rectal mucous membrane that areactually concerned by the surgical treatment.

Another further aim is to provide an anoscope that is more compact,which is useful during transport and/or storage.

Yet another further aim is to provide an anoscope that enables anoperating window to be rapidly and exactly positioned during theperformance of a method for treating haemorroids involving suturingarterial branches located in known positions in relation to the axis ofthe rectum.

In a first aspect of the invention an anoscope is provided, comprising afirst hollow body open at opposite ends and a second hollow body open atopposite ends shapingly coupled with said first hollow body and arrangedto coaxially rotate inside said first hollow body, said second hollowbody being provided with a window arranged to make a portion of rectalmucous membrane accessible, wherein said window has dimensions and ashape such as to enable a surgical device to intervene on said portion.

An anoscope conceived in this manner enables an operating window to besubsequently positioned at different points of the rectal mucousmembrane by acting simply on a part of the anoscope and without havingto rotate the entire instrument.

The operating window is of dimensions such as to ensure access only tothe areas of the rectal mucous membrane that are actually concerned bythe treatment, thereby avoiding the protrusion into the hollow body ofexcessive portions of mucous membrane, with consequent take-up of spacein the field of operation.

Also, the first hollow body comprises a grip that facilitates theinsertion of the anoscope in the rectal canal and can accommodate alight-beam device to enable illumination of the field of operating.

In a further embodiment, the second hollow body may comprise twoseparate segments that can be associated to each other before use insuch a way as to be able to reduce the dimensions of the anoscope duringtransport and storage.

In a second aspect of the invention an anoscope is provided, comprisinga first hollow body open at opposite ends and a second hollow body openat opposite ends shapingly coupled with said first hollow body andarranged to coaxially rotate inside said first hollow body, said secondhollow body being provided with a window arranged to make a portion ofrectal mucous membrane accessible, wherein an angular positioningelement is furthermore provided arranged to adjust the relative angularposition of said second hollow body in said first hollow body in presetreciprocal angular positions.

In an embodiment, said angular positioning element comprises anadjusting ring nut that controls 360° rotation of said second hollowbody, enabling the latter to be locked in six alternative positions,corresponding to the same number of positions taken up by the operatingwindow in relation to the internal rectum wall. Said positions are thesame as the ones indicated by the Sias method for surgical treatment ofhaemorroids disclosed above.

In order that the invention may be clearly and completely disclosed,reference will now be made, by way of examples that do not limit thescope of the invention, to the accompanying drawings, wherein

FIG. 1 shows a rotating operating anoscope complete with dilator;

FIGS. 2 to 7 a show the individual elements making up the anoscope inFIG. 1, namely:

FIG. 2 is a side view of the fixed portion of the anoscope, completewith a grip for the operator;

FIG. 3 is a side view of the segment of movable portion of the anoscopenot comprising the operating window;

FIGS. 4A and 4B are two different side views of the segment of movableportion of the anoscope comprising the operating window;

FIG. 5 is a side view of the dilator contained in the anoscope in FIG.1;

FIG. 6 is an incomplete front view of the fixed portion shown in FIG. 2;

FIG. 7 is a front view of the segment of movable portion shown in FIG.3;

FIG. 7A is an enlarged detail illustrating a device comprised in thesegment of movable portion shown in FIG. 7.

FIG. 8 is an interrupted side view of the anoscope, showing thepositioning mechanism of the operating window.

With reference to FIGS. 1 and 2, a rotating operating anoscope 1comprises a fixed portion 2, comprising in turn a grip 3 that is joinedto a support element 4, made of a material that can be sterilised, forexample steel, and arranged to penetrate the rectal canal through theanal orifice. The grip 3 internally comprises a coaxial optic guide 3′(indicated by a broken line) arranged to accommodate a light-beam device(not indicated) that can be used to illuminate the field of operation,i.e. the internal cavity of the anoscope 1.

The support element 4 comprises a first truncated-cone portion 4 a, asecond truncated-cone portion 4 b and a third truncated-cone portion 4c, that are joined together and internally hollow. The above-mentionedtruncated-cone portions have diameters that decrease from the firsttruncated-cone portion 4 to the third truncated-cone portion 4c, so thatthe end of the support element 4 comprising the base of thetruncated-cone portion 4 a has a diameter that is noticeably greaterthan the diameter of the end opposite the support element 4, comprisingthe truncated-cone portion 4 c.

With reference to FIG. 6, the above-mentioned base of the truncated-coneportion 4 a, which corresponds to the end of the anoscope 1 facing theoperator during use, comprises an edge 4'a that houses a plurality ofnotches 5. More exactly, there are 6 notches arranged at regularintervals along the edge 4'a. By making the edge 4′a coincide with thecircular perimeter of an imaginary clock-face, the positions of the 6notches correspond to the hours: 1, 3, 5, 7, 9, 11.

With reference to FIGS. 1, 3, 4A and 4B, a movable portion 6 isprovided, comprising a rotation segment 6 a and an operating segment 6b, both of which are hollow and are made of a disposable plasticmaterial. The two segments can be associated together through a femalethread F (indicated by a broken line) comprised in the base of theoperating segment 6 b and housing a corresponding thread F′ comprised inthe rotation segment 6 a. The rotation segment 6 a is shapingly coupledwith the support element 4 in such a way that it can be inserted insidethe latter. Once the movable portion 6 has been assembled it can beinserted inside the support element 4 and rotate coaxially by 360° inrelation to the latter. The rotation segment 6 a is made in such a wayas to enable the operating segment 6 b to protrude outside the supportelement 4. The operating segment 6 b is a hollow cylinder that is openat opposite ends and has a side wall 7 interrupted by an operatingwindow 8. The latter is delimited by a U-shaped cut, the convex part ofwhich reaches near the female thread F. The operating window 8 is madein such a way that the convex end of the U-shaped cut corresponds to thepoint that can be reached by the end of the index finger of the hand ofa person of average build by inserting the index finger inside theanoscope. In this way the operating window 8 constitutes the area wherethe operator can enter in direct contact with the rectal mucous membraneto carry out the “Z” surgical sutures provided by the Sias method.

With reference to FIGS. 1, 3, 7 and 7A the movable portion 6 comprises apositioning element 9 that is integral with the rotation segment 6 a andis positioned in such a way as to face the operator during use. Thepositioning element 9 is shaped in the form of a ring comprising aplurality of teeth 10, arranged to facilitate the operator's grip ofsaid toothed element. The teeth 10 comprise a locking tooth 10′ (shownenlarged in detail 7A), that is marked by a navigator 30 and comprises arecess 11 housing a peg 11′. Between the bottom of the recess 11 and theend of the peg 11′ next to said bottom a coil spring 12 is placed bywhich the peg 11′ protrudes outside the recess 11. When the anoscope 1is assembled, as the positioning element 9 is juxtaposed on the edge 4′acomprised in the support element 4 and as the recess 11 is arranged insuch a way that the protruding end of the peg 11′ comes into contactwith said edge, the peg 11′ is forced to retract completely into therecess 11, thereby compressing the spring 12. By rotating thepositioning element 9 by 360° in relation to the fixed portion 4, thelocking tooth 10′ subsequently comes into contact with each of thenotches 5 comprised in the edge 4′a. At each notch 5, the peg 11′ canemerge from the recess 11, assisted by the relaxation of the spring 12,and partially penetrates inside the notch 5. In this way the positioningelement 9, and therefore the movable portion 6, can be locked in each ofthe 6 positions defined by the notches 5. By slightly forcing thepositioning element 9 it can be released and further rotated until itreaches the next notch 5.

The 6 fixed positions that can be reached by the locking tooth 10′correspond to analogous positions of the operating window 8 in relationto the internal wall of the rectum. If for example, as illustrated inFIG. 8, the operator rotates the positioning element 9 until the lockingtooth 10′ fits in the notch 5 corresponding to 9 o'clock, thesimultaneous rotation of the movable portion 6 also places the operatingwindow 8 in the position corresponding to 9 o'clock. In this manner, theoperator, by orienting the anoscope with the grip parallel to theintergluteal sulcus of a patient, can easily reach, through the rotatingoperating window, the zones of the rectal mucous membrane correspondingto those envisaged by the Sias method for surgically treatinghaemorroids.

With reference to FIG. 5, a prior-art dilator 20 is provided, saiddilator being made of a material with a low attrition coefficient (e.g.,Teflon) and which is shapingly coupled with the movable portion 6.

The operator uses the dilator 20 by positioning it inside the anoscope1, when he inserts the latter through the anal region of a patient. Thedilator 20 is shaped in such a way as to dilate the intestinal lumen toprecede and facilitate the entry of the anoscope 1. Once the anoscope 1has been located, the dilator 20 can be extracted, thus making theintestinal lumen accessible to the operator. Before the movable portion6 is rotated, the dilator 20 is reinserted by the operator to relax therectal mucous membrane and thereby facilitate said rotation.

The anoscope 1, in addition to being used for carrying out the Siassurgical method, can be effectively used for: making elastic ligatures,cryotherapy, removing intestinal polyps, administering sclerosinginjections, and carrying out diagnoses and transanal therapy in general.

1. An anoscope comprising a first hollow body open at opposite ends anda second hollow body open at opposite ends shapingly coupled with saidfirst hollow body and arranged to coaxially rotate inside said firsthollow body, said second hollow body being provided with a windowarranged to make a portion of rectal mucous membrane accessible, whereinan angular positioning element is provided to adjust the relativeangular position of said second hollow body in said first hollow body inpreset reciprocal angular positions, said reciprocal angular positionscorresponding to a same number of positions that can be taken up by saidwindow, wherein the first and second hollow bodies are rotatablerelative to one another while the operating window maintains a constantsize and allows access to the rectal mucous membrane at all of saidreciprocal angular positions, wherein said first hollow body comprises afirst truncated-cone portion and has an edge that is comprised in a baseof said first truncated-cone portion, said edge comprising a pluralityof notches, wherein said second hollow body comprises a rotation segmentand an operating segment that can be associated with one another beforeuse, said angular positioning element being integral with said rotationsegment, wherein said angular positioning element comprises a pluralityof teeth, said plurality of teeth comprising a locking tooth thatcomprises a recess housing a peg, wherein the rotation of said angularpositioning element can be locked by an interaction between said peg andeach of said notches.
 2. An anoscope according to claim 1, wherein saidwindow has dimensions and a shape such as to enable a surgical device tointervene on said portion.
 3. An anoscope according to claim 1, whereinsaid first truncated-cone portion is solidly connected with a secondtruncated-cone portion that has a progressively decreasingcross-section.
 4. An anoscope according to claim 3, wherein said secondtruncated-cone portion is solidly connected with a third truncated-coneportion that protrudes from a part opposite said first truncated-coneportion and has a progressively decreasing cross-section.
 5. An anoscopeaccording to claim 1, wherein said window is arranged on said operatingsegment.
 6. An anoscope according to claim 1, wherein said operatingwindow is defined by a U-shaped cut.
 7. An anoscope according to claim1, wherein said window opens near to the point that can be reached bythe tip of an index finger of a hand of an individual of medium build,by inserting said index finger inside said second hollow body.
 8. Ananoscope according to claim 1, wherein said notches are 6 in number. 9.An anoscope according to claim 8, wherein said notches are arrangedalong said edge according to the hours on an imaginary clock-face. 10.An anoscope according to claim 9, wherein said notches are arranged at 1o'clock, 3 o'clock, 5 o'clock, 7 o'clock, 9 o'clock, 11 o'clock.
 11. Ananoscope according to claim 1, comprising an elastic element interposedbetween said peg and the bottom of said recess.
 12. An anoscopeaccording to claim 1, wherein the operating window is positioned beyondthe distal end of the first hollow body.
 13. An anoscope according toclaim 1, wherein the preset angular positions correspond to arterialbranches of a patient's rectal wall.
 14. An anoscope according to claim6, wherein a convex portion of the U-shaped operating window is orientedtowards the first hollow body, and an open end of the U-shaped operatingwindow is arranged at a distal end of the second hollow body.
 15. Ananoscope according to claim 1, wherein the window of the second hollowbody is provided at a distal end of the second hollow body, and thesecond hollow body protrudes outside and beyond a distal end of thefirst hollow body.
 16. An anoscope according to claim 1, wherein thepositioning element includes a locking member that maintains alignmentwith the window during rotation of the second hollow body.